Therapeutic Hypothermia for Hearing Preservation During Cochlear Implants
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Restorear Devices LLC
Disqualifiers: Under 18, Not meeting hearing requirements
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are:
1. Is mild therapeutic hypothermia safe for use during cochlear implantation?
2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation?
Participants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment Intra-Ear Canal Cooling Catheter, Intra-Ear Canal Cooling Catheter, Therapeutic Hypothermia Device, ReSurg for hearing preservation during cochlear implants?
Research shows that applying mild therapeutic hypothermia (cooling) during cochlear implant surgery can help protect the inner ear and preserve hearing by reducing damage and inflammation. Studies have demonstrated that cooling the ear can effectively lower temperatures in the cochlea, which helps protect the delicate hair cells and maintain residual hearing.
12345Is therapeutic hypothermia safe for use in humans during cochlear implant surgery?
Research suggests that using therapeutic hypothermia during cochlear implant surgery is feasible and can be safely achieved with standard surgical irrigation fluids. This cooling method has been shown to protect the inner ear without causing harm.
12345How does the Intra-Ear Canal Cooling Catheter treatment differ from other treatments for hearing preservation during cochlear implants?
The Intra-Ear Canal Cooling Catheter treatment is unique because it uses localized therapeutic hypothermia (cooling) to protect the inner ear during cochlear implant surgery, which helps preserve residual hearing. This approach is different from other treatments as it directly cools the ear canal to reduce trauma and inflammation, which are common causes of hearing loss after surgery.
12345Eligibility Criteria
This trial is for individuals undergoing cochlear implant surgery who are interested in trying a new method to preserve their remaining hearing. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely participating.Inclusion Criteria
Residual hearing from pre-surgical ABR
Equal numbers of CI devices from all 3 manufacturers
I speak English or Spanish.
+5 more
Exclusion Criteria
I am under 18 years old.
Subjects not meeting functional hearing requirements
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgery and Treatment
Participants undergo cochlear implant surgery with mild therapeutic hypothermia delivered via the ear canal
1 day
1 visit (in-person)
Initial Follow-up
Participants are monitored for safety and effectiveness immediately post-operatively and at initial cochlear implant activation
1 month
2 visits (in-person)
Extended Follow-up
Participants are monitored for long-term safety and effectiveness of the treatment
12 months
3 visits (in-person)
Participant Groups
The study is testing the safety and effectiveness of using mild therapeutic hypothermia during cochlear implant surgery. It involves comparing outcomes between patients receiving this cooling therapy and those who do not (control group).
3Treatment groups
Experimental Treatment
Active Control
Group I: Safety StudyExperimental Treatment1 Intervention
Aim 1: Ascertain the safety of the system and device in patients undergoing cochlear implantation (CI). Mild therapeutic hypothermia will be delivered to the subjects during CI surgery via the ear canal.
Group II: Efficacy Study CoolingExperimental Treatment1 Intervention
Aim 2: Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive mild therapeutic hypothermia via the ear canal during cochlear implant surgery.
Group III: Efficacy Study ControlActive Control1 Intervention
Aim 2: Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive standard of care (no cooling) during cochlear implant surgery.
Intra-Ear Canal Cooling Catheter is already approved in United States for the following indications:
🇺🇸 Approved in United States as Intra-Ear Canal Cooling Catheter for:
- Preservation of residual hearing in cochlear implant surgery
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
Restorear Devices LLCLead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
University of MiamiCollaborator
References
Anatomical Correlates and Surgical Considerations for Localized Therapeutic Hypothermia Application in Cochlear Implantation Surgery. [2020]Application of localized, mild therapeutic hypothermia during cochlear implantation (CI) surgery is feasible for residual hearing preservation.
Theoretical Evaluation and Experimental Validation of Localized Therapeutic Hypothermia Application to Preserve Residual Hearing After Cochlear Implantation. [2019]Cochlear implantation surgery has been shown to result in trauma to inner ear sensory structures, resulting in loss of residual hearing. Localized therapeutic hypothermia has been shown in clinical care to be a neuroprotective intervention. Previously, we have shown in an experimental model that localized hypothermia protects cochlear hair cells and residual hearing function against surgical and cochlear implantation trauma. Using experimental temperature measurements carried out in human cadaver temporal bones and a finite element model of the inner ear, the present study examined the temperature distribution of a custom-designed hypothermia delivery system in the human inner ear organs.
Measurement of the Intracochlear Hypothermia Distribution Utilizing Tympanic Cavity Hypothermic Rinsing Technique in a Cochlea Hypothermia Model. [2021]Introduction: Cochlea implants can cause severe trauma leading to intracochlear apoptosis, fibrosis, and eventually to loss of residual hearing. Mild hypothermia has been shown to reduce toxic or mechanical noxious effects, which can result in inflammation and subsequent hearing loss. This paper evaluates the usability of standard surgical otologic rinsing as cooling medium during cochlea implantation as a potential hearing preservation technique. Material and Methods: Three human temporal bones were prepared following standard mastoidectomy and posterior tympanotomy. Applying a retrocochlear approach leaving the mastoidectomy side intact, temperature probes were placed into the basal turn (n = 4), the middle turn (n = 2), the helicotrema, and the modiolus. Temperature probe positions were visualized by microcomputed tomography (μCT) imaging and manually segmented using Amira® 7.6. Through the posterior tympanotomy, the tympanic cavity was rinsed at 37°C in the control group, at room temperature (in the range between 22 and 24°C), and at iced water conditions. Temperature changes were measured in the preheated temporal bone. In each temperature model, rinsing was done for 20 min at the pre-specified temperatures measured in 0.5-s intervals. At least five repetitions were performed. Data were statistically analyzed using pairwise t-tests with Bonferroni correction. Results: Steady-state conditions achieved in all three different temperature ranges were compared in periods between 150 and 300 s. Temperature in the inner ear started dropping within the initial 150 s. Temperature probes placed at basal turn, the helicotrema, and middle turn detected statistically significant fall in temperature levels following body temperature rinses. Irrigation at iced conditions lead to the most significant temperature drops. The curves during all measurements remained stable with 37°C rinses. Conclusion: Therapeutic hypothermia is achieved with standard surgical irrigation fluid, and temperature gradients are seen along the cochlea. Rinsing of 120 s duration results in a therapeutic local hypothermia throughout the cochlea. This otoprotective procedure can be easily realized in clinical practice.
Achieving Mild Therapeutic Hypothermia in the Human Cochlea. [2023]To determine temperature and duration of cooling necessary for achieving cochlear mild therapeutic hypothermia (MTH) via ear canal cooling using cool water and earmold attached to a Peltier device.
A cool approach to reducing electrode-induced trauma: Localized therapeutic hypothermia conserves residual hearing in cochlear implantation. [2021]The trauma caused during cochlear implant insertion can lead to cell death and a loss of residual hair cells in the cochlea. Various therapeutic approaches have been studied to prevent cochlear implant-induced residual hearing loss with limited success. In the present study, we show the efficacy of mild to moderate therapeutic hypothermia of 4 to 6 °C applied to the cochlea in reducing residual hearing loss associated with the electrode insertion trauma.